Woodbine Products Co Inc
FDA inspection history in Medina, Ohio, 2016 to 2026
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2016: one Form 483; 2022: one Form 483; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at Medina, Ohio.
- 2022One Form 483, at Medina, Ohio.
- 2022The longest 483 on file: 8 observations over 6 pages at Medina, Ohio.
- 2026One warning letter, at Medina, Ohio.
Cited most
Across all Woodbine Products Co observations on file
- 21 CFR 211.22Responsibilities of quality control unit4
- 21 CFR 211.166Stability testing2
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures2
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.111Time limitations on production1
The complete Woodbine Products Co file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Medina, Ohio
Two Form 483s and one warning letter · 2016 to 2026 · 15 observations
Latest: Warning letter, Jul 27, 2026 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-07-27 | Warning letter Warning letter | Medina, Ohio | — | $99 |
| 2022-09-01 | 483 Form 483 | Medina, Ohio | 8 | $99 |
| 2016-09-06 | 483 Form 483 | Medina, Ohio | 7 | $99 |
Investigators on these documents
FEI number 1519202 · most recent document Jul 27, 2026
About Woodbine Products Co Inc
How many FDA Form 483s has Woodbine Products Co Inc received?
FDA Intel has 2 Form 483s on file for Woodbine Products Co Inc; the most recent is dated Sep 1, 2022.
When was Woodbine Products Co Inc last inspected by FDA?
The most recent FDA inspection document on file for Woodbine Products Co Inc is a Form 483 dated Sep 1, 2022, for the site in Medina, Ohio.
What did FDA cite at Woodbine Products Co Inc?
The regulations cited most in the observations on file for Woodbine Products Co Inc are 21 CFR 211.22 (Responsibilities of quality control unit), 4 times; 21 CFR 211.166 (Stability testing), 2 times; 21 CFR 211.84 (Testing and approval or rejection of components, drug product containers, and closures), 2 times.
Has Woodbine Products Co Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Woodbine Products Co Inc; the most recent is dated Jul 27, 2026.